Three heart attacks not disclosed in study, editors allege

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The journal said it had made the discovery of the alleged deletions as part of preparations for the recent deposition of the executive editor of the journal in connection with Vioxx-related litigation.

Vioxx maker Merck & Co. concealed heart attacks suffered by three patients during a clinical study of the now-withdrawn painkiller in a report on the study published in the New England Journal of Medicine in 2000, the journal wrote in an editorial released Thursday.

The editorial, written by the journal’s editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and a third doctor, also alleges the study’s authors deleted other relevant data before submitting their article for publication.

“Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article,” the doctors wrote.

Findings of the study in question have been a key part of testimony in the three product liability trials to date over the withdrawn drug, including one being deliberated Thursday by a federal jury in Texas.

In response to the journal's editorial, Merck said "...it is important to emphasize that the company promptly and appropriately disclosed the results of the VIGOR (VIOXX Gastrointestinal Outcomes Research) study. Merck correctly communicated about the benefits and possible risks of VIOXX and extensively disclosed the VIGOR data to the scientific and medical communities, and in the press."

In its statement, Merck added that "The VIGOR publication, which was peer-reviewed, fairly and accurately described the results of the study as of the pre-specified cutoff for analysis. The additional events referred to in the editorial were events that were reported after the pre-specified cut-off date and therefore were not included in the primary analysis reported in the New England Journal article. Nevertheless, these additional events were disclosed to the FDA in 2000, presented publicly at the FDA's Advisory Committee in February 2001, included in numerous press releases subsequently issued by Merck, disclosed to physicians given a copy of the article by Merck and detailed in the updated prescribing information for Vioxx."

Correction requestedIn the journal's editorial, the doctors alleged that excluding the three heart attacks “made certain calculations and conclusions in the article incorrect,” adding that they have asked the report’s authors to submit a correction to the journal.

Merck, in its statement, said it "...looks forward to providing a more complete response to the editorial in the New England Journal of Medicine."

The journal, in its statement labeled "Expression of Concern," said it had made the discovery of the alleged deletions as part of preparations for the recent deposition of the executive editor of the journal in connection with Vioxx-related litigation.

The journal said Merck had submitted its manuscript both on paper and on a computer diskette, but that the journal’s pre-publication review and editing of the story were completely on the printed version of the manuscript.

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The journal said it did not review the diskette until Oct. 5, 2004, several days after Vioxx was pulled from the market after other research showed the popular arthritis drug doubled risks of heart attacks and stroke with long-term use.

"In reviewing the diskette, we learned that data on cardiovascular events had been deleted from the manuscript before it was submitted," the journal said.

One of the study’s authors was Dr. Alise Reicin, Merck’s vice president for clinical research. Reicin on Wednesday testified in the Houston trial that the company never misled doctors and the public about studies linking heart attacks to Vioxx.

The company now faces at least 7,000 lawsuits over Vioxx and legal liability some analysts have estimated at up to $50 billion. Those problems were part of the reason Merck last week announced plans to cut 7,000 jobs and close eight manufacturing and research facilities around the world as the first step in a sweeping reorganization.